A trial to assess the benefit of offering an e-cigarette starter kit to smokers attempting to stop smoking with varenicline

E-cigarettes to Augment Stop Smoking In-person Support and Treatment with varenicline (E-ASSIST): a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16931827

Enrollment

1266

Registered

2018-08-23

Start date

2018-08-01

Completion date

Unknown

Last updated

2022-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco smoking cessation Not Applicable Tobacco smoking cessation

Interventions

Current interventions as of 24/01/2019: Participants will be computer-randomised in a 1:1 ratio into either the intervention of the control group. This study will be limited to Stop Smoking Services (

therefore, participants will be block-randomised in LAs to ensure an equal distribution of control and intervention participants across services. Participants in the intervention group will receive th

a lower nicotine concentration will be offered if the initial concentration is perceived to be aversive) which will last for four weeks. Participants will be given brief in-person advice about how to

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 18 years or older 2. Smoker 3. Attending SSS one-to-one specialist support in London LAs 4. Proficient in English 5. Firm target quit date 6. Elect to use varenicline to support quit attempt 7. Willing to try e-cigarettes

Exclusion criteria

Exclusion criteria: 1. Pregnant 2. Breastfeeding

Design outcomes

Primary

Measure	Time frame
Smoking abstinence, self-reported between weeks 9-12 from the target quit date and validated by an expired air CO concentration of below 10 ppm at week 12	—

Secondary

Measure	Time frame
Current secondary outcomes as of 24/01/2019: 1. CO-validated smoking abstinence between weeks 2-4 from the target quit date, validated using an expired air CO concentration of below 10 ppm 2. Smoking reduction by at least 50% at week 4, assessed by self-reported reduction in cigarettes per day and at least 50% reduction in CO levels from the baseline 3. Retention in SSS, defined as the proportion of attendees who set a target quit date who respond at the 12 week post-quit follow up 4. Adherence to varenicline treatment, defined as the proportion of attendees who set a target quit date who continue using varenicline until the 12 week post-quit follow up 5. The proportion of services approached who agree to deliver the intervention and the proportion of clients within services who agree to take part in the study will be recorded to determine feasibility of intervention implementation 6. For participants that have been in the trial for 6 months, CO –validated smoking abstinence at 6 months following the target quit-date will be measured Previous secondary outcomes: 1. CO-validated smoking abstinence between weeks 2-4 from the target quit date, validated using an expired air CO concentration of below 10 ppm 2. Smoking reduction by at least 50% at week 4, assessed by self-reported reduction in cigarettes per day and at least 50% reduction in CO levels from the baseline 3. Retention in SSS, defined as the proportion of attendees who set a target quit date who respond at the 12 week post-quit follow up 4. Adherence to varenicline treatment, defined as the proportion of attendees who set a target quit date who continue using varenicline until the 12 week post-quit follow up 5. The proportion of services approached who agree to deliver the intervention and the proportion of clients within services who agree to take part in the study will be recorded to determine feasibility of intervention implementation	—

Measure

Time frame

Current secondary outcomes as of 24/01/2019: 1. CO-validated smoking abstinence between weeks 2-4 from the target quit date, validated using an expired air CO concentration of below 10 ppm 2. Smoking reduction by at least 50% at week 4, assessed by self-reported reduction in cigarettes per day and at least 50% reduction in CO levels from the baseline 3. Retention in SSS, defined as the proportion of attendees who set a target quit date who respond at the 12 week post-quit follow up 4. Adherence to varenicline treatment, defined as the proportion of attendees who set a target quit date who continue using varenicline until the 12 week post-quit follow up 5. The proportion of services approached who agree to deliver the intervention and the proportion of clients within services who agree to take part in the study will be recorded to determine feasibility of intervention implementation 6. For participants that have been in the trial for 6 months, CO –validated smoking abstinence at 6 months following the target quit-date will be measured Previous secondary outcomes: 1. CO-validated smoking abstinence between weeks 2-4 from the target quit date, validated using an expired air CO concentration of below 10 ppm 2. Smoking reduction by at least 50% at week 4, assessed by self-reported reduction in cigarettes per day and at least 50% reduction in CO levels from the baseline 3. Retention in SSS, defined as the proportion of attendees who set a target quit date who respond at the 12 week post-quit follow up 4. Adherence to varenicline treatment, defined as the proportion of attendees who set a target quit date who continue using varenicline until the 12 week post-quit follow up 5. The proportion of services approached who agree to deliver the intervention and the proportion of clients within services who agree to take part in the study will be recorded to determine feasibility of intervention implementation

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026